Tissue bonding implantation device and method

ABSTRACT

A tissue bonding implantation device includes an internal drainage tube having an internal surface and an external surface, an inflatable balloon in the shape of a toroid encircling the outer surface of the internal drainage tube, and a balloon inflation conduit in fluid communication with an interior of the inflatable balloon. A transcutaneous sleeve in the form of a tube having an internal diameter allows the sleeve to fit over the external surface of the internal drainage tube, and the sleeve includes a horizontal flange positioned at a top edge of the sleeve. The horizontal flange lies flat on the skin surface. An external cap has a first sealable opening in fluid communication with the internal drainage tube and a second sealable opening in fluid communication with the balloon inflation conduit extending from the balloon to the cap proximate to the sleeve. A tissue-bonding anchor is reversibly attached onto the outer surface of the drainage tube in a watertight manner, via the inflatable balloon.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation of and has benefit of priorityof U.S. patent application Ser. No. 14/648,073, titled “Tissue BondingImplantation Device and Method”, filed on May 28, 2015, which priorityapplication is a 371 and has benefit of priority of internationalApplication No. PCT/US2013/072304, titled “Tissue Bonding ImplantationDevice and Method” filed on Nov. 27, 2013 which was a conversion of andhas benefit of priority of U.S. Provisional Patent Application No.61/731,532, titled “A Tissue Bonding Implantation Device”, filed Nov.30, 2012. The priority application Ser. No. 14/648,073 is co-pending andhas at least one same inventor of the present application and is hereinincorporated by this reference.

TECHNICAL FIELD

The present invention generally relates to cystostomy catheters, andmore particularly relates to tissue bonding implantation devices andmethods for fluid drainage.

BACKGROUND

Clinical applications of transcutaneous catheters include, for example,suprapubic bladder drainage, transcutaneous and intrathoracic access tocentral venous vessels, peritoneal dialysis, and intravascular accessfor chemotherapy, among others. Use of transcutaneous catheters in thesetreatments permit skin microbes to adhere to catheter surfaces tomigrate along the catheter. The microbes then may enter the body byadhering, replicating and migrating within biofilms into intra-corporealorgans.

In the case of suprapubic bladder drainage, in particular, the urinarybladder is a hollow spherical muscle that serves as a muscular reservoirto hold about 8-12 ounces of urine. A sphincter muscle at the bladderoutlet normally closes around the urethra to allow the bladder to fillwith and retain urine. During filling, the bladder is relaxed and thesphincter muscle is contracted. The nervous system normally alerts thebrain when the bladder is near full, triggering an urge to expel theurine contents of the bladder. During normal urination, the braintriggers pelvic nerves that cause the bladder muscle to contract and thesphincter muscle to relax in coordinated manner. Urine is then expelledfrom the bladder through the urethra.

Neurological damage, and other maladies, can impair contraction andcoordination of the bladder and sphincter muscles. Loss of bladdercontrol can result in incontinence. Spinal cord injury (SCI) is anon-exclusive example instance in which neurological damage may disruptor impair normal operation of the urinary bladder. Most SCI patients canhave chronic urinary retention. Some have incontinence and/or acombination of chronic retention with episodic incontinence. A highpercentage of SCI patients use intermittent catheterization, Foleyurethral catheter drainage, and/or suprapubic bladder drainage methodsto evacuate the bladder on a chronic basis.

Foley and suprapubic bladder drainage are open access, meaning that skinmicrobes have constant access to external surfaces of these chronic,indwelling, drainage tubes. Skin microbes adhere to external cathetersurfaces. As microbes replicate, they migrate (mostly) along theexterior catheter surfaces and thereby gain access to the bladder lumen.The external catheter surface is constantly moistened with urine orurethral mucous or both. About 100% of SCI patients utilizing Foleyurethral or suprapubic tube drainage for (on the order of) about >60days have microbial colonized urine. Existing antimicrobial-coated tubesor systemic antibiotics can reduce the colonization rate, for example,from approximately 5%/day to approximately 2-3%/day. This prophylacticuse of antimicrobial agents invites colonization by antibiotic resistantmicrobes.

Bacteria have two life-styles, planktonic (i.e., floating) or sessile(i.e., attached to a surface). Urinary pathogens typically have sugarmolecules on their surface causing them to adhere to catheter surfaceswhere they may multiply rapidly. Concentrations of adherent microbes mayfrequently exceed on the order of about 106/ml in 24 hours and 107/ml in48 hours. Microbial metabolism changes in these sessile, dense microbialcolonies. This phenomenon is called quorum signaling. Quorum signalingcreates microbial biofilms which are slimy mixtures of peptides, aminoacids, proteoglycans, and cellular and microbial debris. The biofilmacts as a sanctuary. Microbes trapped within the biofilm may be, forexample, on the order of about 1000×-10,000× more resistant totraditional antibiotics than are planktonic microbes.

Thus, SCI patients and others that utilize traditional, chronic,indwelling Foley urethral catheters and suprapubic tubes are subject toconstant access of skin microbes to external surfaces of urethralcatheters. Resident skin microbes adhere, multiply explosively, andmigrate as dense colonies along the catheters primarily on the externalsurface into the bladder lumen. These migrating bacteria form biofilmson catheter surfaces that harbor and perpetuate microbial growth andincrease resistance to antimicrobial agents. Antibiotics can sterilizeurine by killing planktonic bacteria but have little or no effect onbiofilm embedded organisms on the catheter surfaces. Thus, continuousaccess of skin microbes to catheter surfaces cause Catheter-AssociatedUrinary Tract Infection [CAUTI] which is widely recognized as a majorchronic problem increasing morbidity rates.

It would therefore be desirable, and a significant improvement in theart and technology, to provide systems, devices and methods fortranscutaneous catheter treatment, including for bladder drainage, on along term basis, which systems, devices and methods prevent or reducebacterial incursion, adhesion, and/or formation of biofilms.

SUMMARY

An embodiment of the invention is a tissue bonding implantation deviceincluding an internal drainage tube having an internal surface and anexternal surface, an inflatable balloon in the shape of a toroidencircling the outer surface of the internal drainage tube, a ballooninflation conduit in fluid communication with an interior of theinflatable balloon, a transcutaneous sleeve in the form of a tube havingan internal diameter allowing the sleeve to fit over the externalsurface of the internal drainage tube, and a cap positioned at a topedge of the sleeve or more distally in the internal drainage tube. Theexternal cap has a first sealable opening in fluid communication withthe drainage tube and a second sealable opening in fluid communicationwith the balloon inflation conduit, the balloon inflation conduitextending from the balloon to the cap proximate to the sleeve, and areversible tissue-bonded anchor that is reversibly attached onto theouter surface of the drainage tube. Inflation of the balloon on theinternal drainage tube reversibly engages and secures the drainage tubein a water-tight manner within the anchor.

Another embodiment of the invention is a tissue bonding implantationdevice including a drainage tube having an internal surface and anexternal surface, an inflatable balloon connected to the drainage tube,on the external surface of the drainage tube, a balloon inflationconduit in fluid communication with the inflatable balloon, the ballooninflation conduit extends through the drainage tube from the inflatableballoon, to an external cap connected to the drainage tube and theballoon inflation conduit, the cap having a first sealable opening influid communication with the drainage tube and a second sealable openingin fluid communication with the balloon inflation conduit, and an anchorforming an inflation void, the inflatable balloon expands via injectionthrough the external cap and balloon inflation conduit. Fluid injectionvia the external cap fills the balloon within the inflation void of theanchor, to retain the drainage tube with the anchor.

Yet another embodiment of the invention is a catheter for connection toa vessel. The catheter includes an anchor connected to the vessel, theanchor includes a first lock device, and a drain tube, the drain tubeincludes a second lock device for reversibly and sealingly mating withthe first lock device.

Another embodiment of the invention is a method of tissue bonding for acatheter. The method includes implanting an anchor to a drain vessel,guiding a drain tube through the anchor, and locking the drain tube tothe anchor.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is illustrated by way of example and notlimitation in the accompanying figures, in which like referencesindicate similar elements, and in which:

FIG. 1 illustrates an exploded view of an example of a tissue bondingimplantation device, according to certain embodiments of the invention;

FIG. 2 illustrates a sectional elevational view of an example of atissue bonding anchor as positioned on a bottom portion of a drainagetube and balloon, according to certain embodiments of the invention;

FIG. 3 illustrates a side perspective view of an exemplary bondingimplantation device, according to certain embodiments of the invention;

FIG. 4 illustrates a partial side view in cross-section along line A-A′of FIG. 3 of an exemplary dual channel cap, according to certainembodiments of the invention;

FIG. 5 illustrates a partial side perspective view of the exemplary dualchannel cap of FIG. 4, according to certain embodiments of theinvention;

FIG. 6 illustrates a front and top perspective view of an exemplarytissue bonding anchor, according to certain embodiments of theinvention;

FIG. 7 illustrates a top view of the exemplary tissue bonding anchorwith example sutures, according to certain embodiments of the invention;and

FIG. 8 illustrates a partial side view in vertical cross-section of anexemplary in use tissue bonding implantation device, according tocertain embodiments of the invention.

DETAILED DESCRIPTION

A non-exclusive embodiment according to the present invention of atissue bonding implantation device includes an internal drainage tubehaving an internal surface and an external surface, an inflatableballoon in the shape of a toroid encircling the outer surface of theinternal drainage tube, a balloon inflation conduit in fluidcommunication with an interior of the inflatable balloon, atranscutaneous sleeve in the form of a tube having an internal diameterallowing the sleeve to fit over the external surface of the internaldrainage tube, and an external cap that is variably positioned at asevered end of the internal drainage tube or at the distil end of theinternal drainage tube, the cap has a first sealable opening in fluidcommunication with the drainage tube and a second sealable opening influid communication with the balloon inflation conduit, the ballooninflation conduit extending from the balloon to the cap proximate to thesleeve, and a tissue-bonding anchor that bonds in a water-tight mannerto the internal drainage tube when the balloon on the internal drainagetube is inflated with air or a fluid such as water or saline.

Referring to FIG. 1, a non-exclusive example embodiment of a tissuebonding device 100 includes an internal drainage tube 2. The internaldrainage tube 2 is hollow. A bottom portion 4 of the drainage tube 2may, but need not necessarily, be inwardly tapered. Although illustratedas a tube having a generally cylindrical cross sectional shape in FIG.1, the drainage tube 2 may have any acceptable cross sectional shapeprovided a transcutaneous sleeve 314 (not shown in FIG. 1, but laterdescribed and shown in FIGS. 3, 8 and 9) is appropriately shaped tomatch that of the drainage tube 2. The drainage tube 2 is designed to beimplanted internally in a body such that an opening (or series ofopenings, as applicable) on the lower end of the drainage tube 2 is influid communication with a fluid to be removed from or injected into abody.

An inflatable balloon 6, for example, generally in the shape of a toroidor otherwise, surrounds an outside surface of the drainage tube 2. Aninterior of the inflatable balloon 6 is in fluid communication with aballoon inflation conduit 8. The balloon inflation conduit 8 extendsfrom the balloon 6 to a cap 12 and permits the introduction and releaseof fluids into the inflatable balloon 6. Such fluids may include, by wayof example, water, saline and air.

In certain embodiments, the transcutaneous sleeve 314 (shown in FIGS. 3,8 and 9) is a hollow tube designed to fit around the internal drainagetube 2 and to lie beneath the skin within subcutaneous fat. In oneembodiment, the transcutaneous sleeve 314 has a flange 330 (shown inFIGS. 3, 8 and 9) connected to an upper edge of the sleeve such that theflange sits on the skin surface.

As shown in FIG. 1, the removable external cap 12 is configured to seala top opening 18 of the drainage tube 2 and a top opening 11 of theballoon inflation conduit 8. The cap 12 may be attached to the end ofthe internal drainage tube 2 or at any point where the internal drainagetube 2 may be severed during insertion, for example, typically theinternal drainage tube 2 is severed flush with the skin surface. Theexternal cap 12 is designed to insert into both channels (i.e., theballoon inflation conduit 8 and the drainage channel of the drainagetube 2, itself) of the internal drainage tube in a watertightfriction-fit manner.

Referring to FIG. 2, an embodiment of a tissue-bonding anchor 200 isshown in cross section. The tissue-bonding anchor 200 becomes bonded ina water-tight and reversible manner to the internal drainage tube 2 whenthe balloon 6 on the internal drainage tube 2 is inflated with a fluid,gas, or air (i.e., within an expanded balloon chamber 26, as hereafterdescribed). The anchor 200 includes, for example, a silicone flange 20(oriented horizontally in FIG. 2) and a silicone cylinder 22 (orientedvertically in FIG. 2). The top and bottom external surfaces 20 a, 20 b,respectively, of the flange 20 and a portion of the cylinder 22 arecoated with a porous polymer such as polytetrafluoroethylene (PTFE,e.g., Teflon™) or polyester (e.g., Dacron™). Only the cylindricalsegment 24 adjacent to the silicone flange 20 is coated with porouspolymer; this partial coating is designed to keep the porous polymerbelow the recuts abdominis fascia and within the rectus abdominismuscle. The anchor 200 contains an expanded chamber 26 within thecylindrical segment 24 that is designed to accept the inflated balloon 6in a secure and water-tight manner. The anchor 200 is designed to bepermanently implanted into the body by, for example, suturing or othersuitable bonding. The anchor 200 may be attached extra-peritoneally,such that the internal drainage tube 2 is in fluid communication withthe desired body component, for example, the urinary bladder. Ideally,the anchor can be, for example, inserted into potential space surgicallydeveloped within the body wall bounded anteriorly by the rectusabdominis muscle and posteriorly by the transversalis fascia.

The remainder of the components are preferably made of silicone. Thetranscutaneous sleeve 318 (shown in FIGS. 3, 8 and 9) is preferablyimpregnated or coated with antimicrobial agents. The antimicrobialmolecules may be elutable or non-elutable bonded to the external surfaceof the sleeve. Antimicrobial quantities, such as are known in the art,such as biofilm dispersants, quorum signaling inhibitors, slick surfacemolecules, anti-fungals, bacteriostatic agents and bactericidal agentsmay be used. Therapeutic concentrations of these agents may elute or notelute, as desired in the application, so as to deliver their therapeuticeffect to microbes, fungi, and viruses that seek to attach and replicateon the device surfaces. Certain materials of construction for thevarious components of the tissue bonding device include, for example,the tissue-bonding anchor 200 is made of silicone, polyurethrane, orother synthetic polymer or metal with an outer layer of porous polymer,such as, for example, polytetrafluoroethylene (PTFE) or polyester, onall or a portion of the anchor 200. The anchor 200 may be of variedshape, for example, as a three-dimensional ellipsoid with a smoothexternal surface externally, having the expanded chamber 26 for theballoon being totally contained within the 3-D ellipsoid, or othersuitable or desired configuration.

Referring to FIG. 3, a non-exclusive embodiment of a tissue bondingimplantation device 300 includes a drainage tube 302. The drainage tubeis hollow and may be cylindrical or have other suitable cross sectionalshape for extending into a human body via an opening of the body, suchas a cystostomy or other body opening. The drainage tube 302 includes anexternal portion 302 a and an internal portion 302 b. In use, theexternal portion 302 a extends external to a mammalian body from acystostomy or other body opening, and the internal portion 302 b of thedrainage tube 302 extends into and through the cystostomy or other bodyopening to access, fill, or drain a region, cavity or space such aswithin the urinary bladder or some other organ, space or potentialspace. In this manner the drainage tube passes transcutaneously into themammalian body, with the external portion 302 a residing external to thebody and the internal portion 302 b extending in the body into the drainregion. In FIG. 3, the external components 302 a are permanentlyattached to the internal drainage tube 302 b. External components 302 amay be used as illustrated. Alternatively, tube 302 can be severed abovea distal or bottom end (at 304 in FIG. 3), commonly at the skin surface,for example, and the removable external cap 10 (shown in FIG. 1) orsimilar element(s) may be substituted for components 302 a.

The internal portion 302 b of the drainage tube 302 extends to a bottomend 316. A settlement ring 304 is fixed to and encircles the exteriorcross section of the drainage tube 302 a distance from the bottom end316. The internal portion 302 b, from the settlement ring 304 to thebottom end 316, is sized to fit within the drain region, for example,within the urinary bladder or other drain region, and to allow adequatedrainage from the drain region. Towards the bottom end 316 along thedrainage tube 302, the drainage tube 302 is formed with holes 318through the wall of the tube 302. The holes 318 allow fluids of thedrain region to flow from outside the tube 302, through the wall of thetube 302, and within the hollow of the tube 302. Or, alternatively, ifthe drainage tube 302 is employed for delivery of fluids, the fluidspass within the hollow of the tube 302, through the holes 318 of thewall of the tube 302, and outside the tube 302 in vicinity of the holes318.

An anchor 312 of the tissue bonding catheter implantation device 300includes a central cylinder 319 forming a central channel 320 throughthe anchor 312. The central channel 320 is sized to accommodate thebottom end 316 extending into and through the central channel 320 of thecentral cylinder 319. An accommodation seat 322 at an upper end (in theorientation of FIG. 1) of the central channel 320 is sized to mate withthe settlement ring 304 upon passage of the bottom end 316 into theupper end (in the orientation of FIG. 1) of and through the centralchannel 320. The internal drainage tube 302 may be tapered so that itinserts snugly and in a watertight manner with the bottom aperture ofthe central channel 320 concurrently with the mating of the accomodationseat 322 and settlement ring 304.

An inflatable balloon 306 is fixed externally to the drainage tube 302below (in the orientation of FIG. 3) the settlement ring 304. Theinflatable balloon 306 is, for example, toroidal in shape and encirclesthe drainage tube 302 in connection thereto. Although not shown indetail in FIG. 3, the anchor 312 is formed with an internal ballooninflation void 608 (shown in FIGS. 6 and 8) along the central channel320. The internal balloon inflation void 608 is sized to accommodate theinflatable balloon 306 when inflated, with the bottom end 316 extendinginto the upper end (in the orientation of FIG. 1) of the centralcylinder 319 through the central channel 320, such that the settlementring 304 rests in the accommodation seat 322.

Continuing to refer to FIG. 3, the external portion 302 a of thedrainage tube 302 is sized to extend externally from the body when theinternal portion 302 b resides in the body. A permanently attachedterminal end (upper end in the orientation of FIG. 3, with details shownin FIGS. 4 and 5) of the external portion 302 a is connected to or formsa dual-channeled cap 324. A first channel 308 of the dual-channeled cap324 extends the drainage tube 302 to form a channel for connection to adrain conduit 334. The drainage tube 302 provides a channel for flow offluids into the tube 302 from a region, through the tube 302, andpassing to and through the first channel 308 of the cap 324. In thismanner, the drainage tube 302 and first channel 308 provide a conduitfor drainage of a fluid, for example, urine (or other fluid, asapplicable), from a drainage region, for example, the bladder (or otherregion, as applicable). A connector 327 at an upper end (in theorientation of FIG. 1) of the first channel 308 may be connected to adrain tube 334 or similar conduit, for example, the drain tube 334connects to a collection bag or collection reservoir for drained fluids.

Continuing to refer to FIG. 3, (with reference to FIG. 4), a secondchannel 309 of the dual-channeled cap 324 forms a valved externalinflation conduit 310. The external inflation conduit 310 connectsthrough the first channel 308 to an internal inflation conduit 402 (notshown in detail in FIG. 3, but shown in FIGS. 4, 5 and 8). The internalinflation conduit 402 passes within the drainage tube 302 and connectsto the inflatable balloon 306. The inflatable balloon 306 is inflatablevia the valved external inflation conduit 310 and the internal inflationconduit 402. A source (not shown in detail) of a pressurized fluid, suchas saline, air or other gas or liquid, is connected to the valvedexternal inflation conduit 310 to admit the pressurized fluid into theinternal inflation conduit 402 and on to the inflatable balloon 306.

The dual-channeled cap 324 may also include wing tabs 326 or otherextensions to assist handling and management of the external portion 302a of the drainage tube 302. For example, the wing tabs 326 providesurface for taping or securement of the external portion 302 a to theexternal skin of the body or otherwise. Although not shown in FIG. 3(but shown as a non-exclusive example, in FIGS. 4 and 5), one or moreplug or cap may provide sealed containment of fluids by thedual-channeled cap 324.

A transcutaneous sleeve 314 of the tissue bonding catheter implantationdevice 300 includes a hollow transcutaneous extension 328 connected to adisk flange 330. The transcutaneous extension 328 and the disk flange330 include a slit 332. Via the slit 332, the transcutaneous sleeve 314is flexed to enlarge the opening of the slit 332 to accept the drainagetube 302 in the transcutaneous extension 328, in vicinity of theintersection of the internal portion 302 b and external portion 302 b,such that the drainage tube 302 extends within the hollow transcutaneousextension 328. In use with the body and the drainage tube 302, thetranscutaneous extension 328 is placed at the cystostomy or other bodyopening and inserted to extend through the skin of the body, until thedisk flange 330 rests on the skin. In this manner, the transcutaneoussleeve 314 shields the drainage tube 302 from contact with the skin andcutaneous layers. The transcutaneous sleeve 314, via the slit 332, maybe replaced by flexing the sleeve 314 to open the slit 332 and removethe sleeve 314 from around the drainage tube 302, and providing a nextsleeve 314 to the tube 302, to avoid microbe contamination of thedrainage tube 302 from the skin and subcutaneous layers. Thetranscutaneous sleeve 314 also serves to fill the potential void spaceabove the settlement ring 304 (shown in FIGS. 3 and 8). In operation,the anchor 312 is surgically affixed, such as by sutures or other bond,to a wall of an organ, space or potential cavity such as a muscular orother reservoir within a mammalian body (for example, the wall of thebladder if the tissue bonding catheter implantation device 300 isemployed for bladder urine drainage). The internal portion 302 b of thedrainage tube 302 is fed, via a cystostomy opening or otherwise, throughthe central channel 320 of the anchor 312, until the settlement ring 304mates with the accommodation seat 322. In this manner, the bottom end316 of the drainage tube 302 resides in the preferred access location ordrain vessel, such as the bladder, to allow drainage from the drainvessel through the holes 318 and in the drainage tube 302.

Upon mating of the settlement ring 304 to the accommodation seat 322,the inflatable balloon 306 is positioned to be inflated, via the valvedexternal inflation conduit 310 forming the second channel 309 andthrough the internal inflation conduit 402. The inflatable balloon 306is inflated sufficiently to inflate the internal balloon within theinflation void 608 (not shown in FIG. 4, but shown in FIGS. 6 and 8) ofthe anchor 312. The inflatable balloon 306, as so inflated, forms afluid impermeable seal with the anchor 312. The inflatable balloon 306,as so inflated, also retains the drainage tube 302 in engagement to theanchor 312 and extending into the drain vessel, such as the bladder. Thedrain vessel, such as the bladder, then drains through the drainage tube302 and through the first channel 308.

The first channel 308 may be connected by the connector 327 to acollection bag, such as a urine collection bag or tube to such bag oranother collector. The transcutaneous sleeve 314 may be placed, andreplaced, in engagement with the drainage tube 302 at a cystostomy orother body opening, to shield the tissue bonding catheter implantationdevice 300 from contact with the skin and transcutaneous layers of thebody adjacent the drainage tube 302. The drainage tube 302 may beinserted over a guide wire (not shown) through the cystostomy andcentral channel 320 of the anchor 312, such that the bottom end 316extends through the drainage reservoir (e.g., bladder) wall and into thereservoir (e.g., in the bladder). The balloon 306 is inflated to sealthe tube 302 to the anchor 312. The drainage tube 302 may be removedupon deflation of the balloon 306, and then replaced through sameprocedure to again seal against the anchor 312. Referring to FIGS. 4 and5, in conjunction with FIG. 3, a non-exclusive embodiment 400 of thedual-channel cap 324, shown in cross-section taken along line A-A′ ofFIG. 1, includes the internal inflation conduit 402. The internalinflation conduit 402 extends from the valved external inflation conduit310, to the internal balloon inflation void 608 (not shown in FIG. 4,but shown in FIGS. 6 and 8), within the hollow drainage tube 302 (shownin FIGS. 3 and 8). The valved external inflation conduit 310 contains avalve 404. The valved external inflation conduit 310 connects to aninflation inlet 406. The inflation inlet 406 is hollow 408 and sized tomate with a source of pressurized fluid, for example, saline, otherliquid, air or gas (not shown in FIG. 4). The valve 404 allowspressurized fluid or gas of the source to be passed via the hollow 408into the internal inflation conduit 402 to inflate the inflatableballoon 306 (shown in FIGS. 3 and 8), when the source is connected tothe inflation inlet 406. The valve 404 prevents escape of thepressurized fluid or gas, and thus the inflatable balloon 306 remainsinflated, unless selectively allowed to escape by manual operation todeflate the balloon 306 (e.g., on removal or replacement of the drainagetube 402 in a mammalian body).

The dual channel cap 324 may, but need not necessarily include aremovable plug cap 410 of the first channel 308. The plug cap 410 may beconnected to an outer wall of the first channel 308 near an externaldrain outlet 412 of the first channel 308. Although not shown in FIG. 4(but shown in FIG. 3), the external drain outlet 412 can include theconnector 327 for coupling the external drain outlet 412 to a tube orconduit of a drainage collection bag, such as a urine collection bag.

A lateral wing 414 of the dual-channel cap 324 extends between the firstchannel 308 and the second channel 309 and valved external inflationconduit 310, to connect the first channel 308, second channel 309 andinflation conduit 310, in relatively fixed relation. In operation, theanchor 312 is bonded to an external wall of a drain vessel, for example,the anchor 312 is implanted via surgical procedure to bond the anchor312 to the bladder or to other body wall surfaces at an entry (e.g.,cystostomy or other) near and adjacent to the bladder. The anchor 312 asso implanted is sandwiched and secured (such as by sutures or otherbond) extra-peritoneally, between the detrusor (bladder) and adjacent toor in contact with the rectus abdominus muscles. The drainage tube 302is thereafter inserted via surgical procedure, through a cystostymy andthrough the central channel 320 of the anchor 312, to extend into adrain vessel, space or reservoir, such as the bladder, at the bottom end316. The settlement ring 304 mates with the accommodation seat 322 ofthe anchor 312. The inflatable balloon 306 is then inflated by fluid orgas (e.g., saline, water, air, or other liquid or gas) via the valvedexternal inflation conduit 310, to expand against the internal ballooninflation void 608 of the anchor 312. Upon inflation of the inflatableballoon 306, the inflatable balloon 306 seals against the internalballoon inflation void 608 of the anchor 312, creating a liquid barrierfor drain vessel fluids and retaining the drainage tube 302 to theanchor 312. Drain vessel fluids, for example, urine of the bladder,drain into the holes 318 and through the drainage tube 302 for exitthrough the first channel 308 of the dual-channel cap 324. A drainconduit 334, such as a drain conduit of a urine collection bag, may beconnected to the external drain outlet 412 of the first channel 304. Inembodiments including the plug cap 410, the plug cap 410 is unpluggedfrom the external drain outlet 412 of the drainage tube 302, and thedrain conduit is connected to the external drain outlet 412.

If it is desirable or becomes necessary to remove the drainage tube 302from the drain vessel, the valve 404 of the valved external inflationconduit 310 is manually or otherwise, as applicable, triggered to open,allowing the pressurized fluid or gas within the inflatable balloon 306to escape via the internal inflation conduit 402. A guidewire is theninserted through the drainage channel into the lumen of the cavity,space or organ, for example, the urinary bladder. Once escaped, thedrainage tube 302 is manually passed from the anchor 312 and out thecystostomy leaving the guidewire in-situ. A same or different drainagetube may then be passed over the guidewire to be positioned in exactlythe same location as the drainage tube 302 just removed. The newinternal drainage tube is then fixed to the anchor 312 by inflation ofthe retention balloon within the anchors as desired and in the mannerdescribed.

Referring to FIG. 6, in conjunction with FIGS. 3-5, a non-exclusiveembodiment 600 of the anchor 312 is a flange 602 and central cylinder604. The flange 602 is joined with the central cylinder 604. The flange602 includes attachment holes 604 through the thickness of the flange602. The central cylinder 604 is hollow, forming the central channel 320sized to accommodate the bottom end 316 of the drainage tube 302 throughthe central channel 320. The central channel 320 includes within thecentral cylinder 604 an expansive segment forming an internal ballooninflation void 608. The internal balloon inflation void 608 is sized toaccommodate the inflatable balloon 306, when inflated within the boundsof the internal balloon inflation void 608, in sealed engagement withthe anchor 312. The accommodation seat 322 is formed in an upper end (inthe orientation of FIGS. 1 and 6) of the central channel 320. Theaccommodation seat 322 is sized to mate with the settlement ring 304 ofthe drainage tube 302 when the bottom end 316 of the drainage tube 302is passed through the central channel 320.

Referring to FIG. 7, in conjunction with FIGS. 3-6, a non-exclusiveembodiment of an attached anchor 700 includes attachments 702. Theattachments 702 are, for example, sutures or other suitable bondconnectors for fixing the anchor 312 to a drain vessel, such as thebladder. The attachments 702 pass through the attachment holes 606 ofthe flange 602 and the central cylinder 604, and in use, secure theanchor 312 to the drain vessel.

Referring to FIG. 8, in conjunction with FIGS. 3-7, a non-exclusiveembodiment of an in use tissue bonding implantation device 800, shown invertical cross-section in FIG. 8, includes the drainage tube 302 fixedto the anchor 312 in use in a mammalian body. A cystostomy formed in themammalian body is through the abdominal wall 804 and the bladder wall806 a and bladder lining 806 b. The anchor 312 is placed in theintra-abdomen space 810 at the opening of the bladder wall 806 a. Thecentral channel 320 of the anchor 312 is aligned with the opening of thebladder 808, and the anchor 312 is attached to the bladder wall 806 a byattachments 702, for example, by sutures or other suitable attachmentbond device(s). The attachments 702 are passed through the bladder wall806 a and into the bladder lining 806 b to secure the anchor 312.

The bottom end 316 of the drainage tube 302 is passed through thecentral channel 320 and into the bladder 808, until the settlement ring304 mates with the accommodation seat 322 of the anchor 312. Theinflatable balloon 306 is inflated through the internal inflationconduit 402 and expands in the internal balloon inflation void 608, toseal the drainage tube 302 to the anchor 312 (and, consequently, thebladder 808) and retain the drainage tube 302 to the anchor 312. Thebody may be shielded from contact with the drainage tube 302 by thetranscutaneous sleeve 314. The hollow transcutaneous extension 328 ofthe transcutaneous sleeve 314 wraps the drainage tube 302 and ispositioned within the body to the extent of the disk flange 330 of thetranscutaneous sleeve 314. The transcutaneous sleeve 314 may bereplaceable to avoid microbe contamination of the drainage tube 302 fromthe body.

Referring to FIG. 9, in conjunction with FIGS. 3 and 8, a non-exclusiveembodiment 900 of the transcutaneous sleeve 314 includes the disk flange330 connected to the hollow transcutaneous extension 328. The diskflange 330 and the hollow transcutaneous extension 328 include a slit322 extending radially in the disk flange 330 and connecting alonglength of the transcutaneous extension 328. The transcutaneous sleeve314 is flexible (e.g., manually), separating the slit 322 sufficient towrap the transcutaneous sleeve 314 around the drainage tube 302. Theexternal surface of the sleeve 314 may, in certain non-exclusiveembodiments, be impregnated or coated with one or multiple antimicrobialsurface technologies including modulated surface patterns, modulatedsurface roughness and impregnated or coated molecules. Target moleculesare those that block or repel microbial adhesion, microbialmultiplication or replication and/or that prevent, block or dispersemicrobial formation of biofilms.

Referring to FIG. 10, in conjunction with FIGS. 3-8, a non-exclusiveembodiment of the tissue bonding implantation device 300 is in use fordrain of the bladder 806 in a mammalian body shown in verticalcross-section. The drainage tube 302, via the connector 327 of the firstchannel 308 of the dual-channel cap 324 is coupled to a tube extension902 or other conduit device. The tube extension 902 permits drain fromthe drainage tube 302 to selectively be capped (as shown in FIG. 10) orotherwise opened to flow to a collection bag or other disposal (notshown).

The bottom end 316 of the drainage tube 302 is retained in the bladder806 by the seal of the inflatable balloon 306 in the anchor 312 attachedto the bladder wall 806 a and bladder lining 806 b. The inflatableballoon 306 is inflated (or if desired deflated, for removal of thedrainage tube 302 from the body) through the valved external inflationconduit 310 and internal inflation conduit 402 connected to theinflatable balloon 306. The transcutaneous sleeve 314 is placed aroundthe drainage tube 302, such that the transcutaneous sleeve 314 remainsoutwardly concentric with the drainage tube 302 protruding into thecystostomy with the drainage tube 302 and the disk flange 330 resides onthe skin of the body surrounding the cystostomy opening. Thetranscutaneous sleeve 314 shields the drainage tube 302 from microbialmigration from the body. The transcutaneous sleeve 314 may be replaced,without displacement of the anchor 312 and drainage tube 302 assemblyfrom the body.

Any suitable materials tolerable by the mammalian body or other sourceof drain vessel, are possible for construction of the tissue bondingimplantation device. For example, the anchor 312 may be formed of asilicone cylinder-flange or as a 3 dimensional ellipsode with internalballoon chamber. The basic construct may be fabricated from any metal orsynthetic polymer of which the body is tolerant, including, for example,silicone, polyurethrane, poly vinyl, or other suitable materials, suchas latex, silicone elastomers, or others. The top and bottom surfaces ofthe anchor 312 may be coated with a porous polymer, for example, PTFE,Dacron, other polyester or other substance. The drainage tube 302, aswell as the settlement ring 304 and connector 327, may be formed ofsilicone, latex, silicone elastomers, or other suitable materials. Thebottom end 316 may be tapered to aid placement in the anchor 312. Thedual-channel cap 324 may similarly be formed of silicone, plastics,polyvinyl chloride (PVC), or other suitable materials. The valve may beformed of plastic, metal, silicone, latex or other suitable material,and may be selectively manually (or otherwise) activated to open andclose, for example, by connection of a pressurized fluid or gas sourceto the external inflation conduit 310. The inflatable balloon 306 may berubber or other suitable material formed as a toroid (or other suitableconfiguration), to seal the drainage tube 302 to the anchor 312. Thetranscutaneous sleeve 314 may be formed of silicone or other ductilematerial tolerable by the body. The transcutaneous sleeve 314 may beimpregnated or surfaced with an antimicrobial agent, for example, anelutable, lubricious coating like that provided bypolyvinyl-pyrillodine—or other known coating in the medical deviceindustry.

In operation, the tissue bonding anchor 312 is attached through asurface, such as the skin and abdominal rectus muscles, to a reservoir,such as the bladder or other vessel. The anchor 312 is attached, forexample, by sutures or other bonding device(s) that allows the anchor toimplant to the vessel but be removed from attachment if necessary. Thebottom end 316 of the drainage tube 302 is retained in the bladder 806by the seal of the inflatable balloon 306 in the anchor 312 attached tothe bladder wall 806 a and bladder lining 806 b. The inflatable balloon306 is inflated (or if desired deflated, for removal of the drainagetube 302 from the body) through the valved external inflation conduit310 and internal inflation conduit 402 connected to the inflatableballoon 306. The transcutaneous sleeve 314 is placed around the drainagetube 302, such that the transcutaneous sleeve 314 remains outwardlyconcentric with the drainage tube 302 protruding into the cystostomywith the drainage tube 302, and the disk flange 330 resides on the skinof the body surrounding the transcutaneous cystostomy opening. Thetranscutaneous sleeve 314 shields the drainage tube 302 from microbialmigration from the skin and transcutaneous layers of the body. Thetranscutaneous sleeve 314 may be replaced, without displacement of theanchor 312 and drainage tube 302 assembly from the body.

Two phases of separate procedures, i.e., Phase I and Phase II, may, forexample, be employed for implantation and activation of the tissuebonding device. The anchor is placed in a Phase I minor surgicalprocedure. Phase II, insertion and activation of the drainage tube tothe anchor, may be implemented in separate procedure, for example, inthe case of the bladder, Phase II may be performed about three or moremonths after Phase I. The three-month (or more) time interval allowsfibroblastic in-growth and fixation of the anchor to the rectus anddetrusor muscles. Phase II is a minor fluoroscopic-clinic procedure. Inthe Phase II procedure, the drainage tube is inserted over a guide wireinto the bladder lumen via a small skin incision and needle puncturethrough the bladder wall. The drainage tube is inserted over the guidewire and locks reversibly and mechanically within the tissue-bondedanchor.

The drainage tube is therefore easily replaced, for example, monthly, byunlocking the drainage tube from the anchor through deflation of theballoon, insertion of a guide wire into the bladder lumen, removal andreplacement of a new drainage tube over the guide wire, re-engagement ofthe locking mechanism by inflation of the balloon, and re-attachment ofthe external components. Drugs, e.g., antibiotics and mucosa modulatingagents like Botox, can be injected directly into the bladder lumen viathe self-sealing silicone injection port of the dual channel permanentlyattached or the separately attached cap.

If it becomes necessary, the anchor may be replaced through surgicalprocedure to remove the anchor from the bladder and to implant a newanchor to the bladder.

In the foregoing specification, the invention has been described withreference to specific embodiments. However, one of ordinary skill in theart appreciates that various modifications and changes can be madewithout departing from the scope of the present invention as set forthin the claims below. Accordingly, the specification and figures are tobe regarded in an illustrative rather than a restrictive sense, and allsuch modifications are intended to be included within the scope of thepresent invention.

Benefits, other advantages, and solutions to problems have beendescribed above with regard to specific embodiments. However, thebenefits, advantages, solutions to problems and device(s), connection(s)and element(s) that may cause any benefit, advantage, or solution tooccur or become more pronounced are not to be construed as a critical,required, or essential feature or element of any or all the claims. Asused herein, the terms “comprises, “comprising,” or any other variationthereof, are intended to cover a non-exclusive inclusion, such that aprocess, method, article, or apparatus that comprises a list of elementsdoes not include only those elements but may include other elements notexpressly listed or inherent to such process, method, article, orapparatus.

What is claimed is:
 1. A tissue bonding implantation device, comprising:a drainage tube having an internal surface and an external surface; aninflatable balloon connected to the drainage tube, on the externalsurface of the drainage tube; a balloon inflation conduit in fluidcommunication with the inflatable balloon, the balloon inflation conduitextends through the drainage tube from the inflatable balloon; anexternal cap connected to the drainage tube and the balloon inflationconduit, the cap having a first sealable opening in fluid communicationwith the drainage tube and a second sealable opening in fluidcommunication with the balloon inflation conduit; and an anchor formingan inflation void, the inflatable balloon expands via through theexternal cap and balloon inflation conduit inflation in the inflationvoid of the anchor, to retain the drainage tube with the anchor.
 2. Thetissue bonding implantation device of claim 1, wherein inflation of theretaining balloon of the drainage tube within the inflation void of theanchor, reversibly and watertightly secures the internal drainage tubewithin the anchor.
 3. The tissue bonding implantation device of claim 1,wherein the drainage tube is inwardly tapered along a bottom end of thedrainage tube.
 4. The tissue bonding implantation device of claim 1,wherein the drainage tube has side holes that allow urine to enter theinternal drainage tube along a bottom end of the drainage tube.
 5. Thetissue bonding implantation device of claim 4, wherein the drainage tubeincludes an end-hole that allows the internal drainage tube to be passedand positioned over a temporary guidewire.
 6. The tissue bondingimplantation device of claim 1, further comprising: a transcutaneoussleeve having a flange extending laterally from an upper edge of atranscutaneous extension of the sleeve.
 7. The tissue bondingimplantation device of claim 6, wherein the transcutaneous sleeve ismade of silicone impregnated with nitrofurazone.
 8. The tissue bondingimplantation device of claim 1, further comprising an external drainagetube configured to be removably connected to the external cap.
 9. Thetissue bonding implantation device of claim 1, wherein the secondsealable opening of the cap is made of self sealing silicone.
 10. Acatheter for connection to a vessel, comprising: an anchor connected tothe vessel, the anchor includes a first lock device; and a drain tube,the drain tube includes a second lock device for reversibly andsealingly mating with the first lock device.
 11. The catheter of claim10, further comprising: an external cap connected to the drain tube, theexternal cap includes a first conduit for draining the vessel via thedrain tube and a second conduit connected to the second lock device;wherein the second lock device is actuated via the second conduit toreversibly and sealingly mate with the first lock device.
 12. Thecatheter of claim 11, further comprising: a sleeve having an extensionfor circling the drain tube and a flange.
 13. A method of tissue bondingfor a catheter, comprising the steps of: implanting an anchor to a drainvessel; guiding a drain tube through the anchor; and locking the draintube to the anchor.
 14. The method of claim 13, wherein the step oflocking reversibly and sealingly connects the drain tube to the anchor.15. The method of claim 13, further comprising the step of: shieldingthe drain tube by a sleeve.
 16. The method of claim 13, wherein thesteps of guiding and locking are performed after the step of implanting.17. The method of claim 13, wherein the vessel is a bladder and theanchor is bonded to the bladder in the step of implanting; wherein thesteps of guiding and locking are performed about three months after thestep of implanting.
 18. The method of claim 17, further comprising thestep of: shielding the drain tube from skin and transcutaneous abdomenlayers, via a sleeve.
 19. The method of claim 18, wherein the sleeve isreplaceable to avoid microbial contamination.
 20. The method of claim13, wherein the anchor is removable and replaceable.